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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06840080




Registration number
NCT06840080
Ethics application status
Date submitted
22/01/2025
Date registered
21/02/2025

Titles & IDs
Public title
OEA and LipiSperse Metabolic Study
Scientific title
Short-term Effect of Oleoylethanolamide (OEA) and LipiSperse Supplementation on Metabolic Pathways in Otherwise Healthy Participants - a Single Blind, Cross-over Study
Secondary ID [1] 0 0
GLP1PK
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers - Male and Female 0 0
Pharmacokinetic Study in Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Placebo
Treatment: Other - 125mg OEA with LipiSperse
Treatment: Other - 250mg OEA with LipiSperse

Placebo comparator: Placebo - Single dose of 2 capsules will be administered that appear identical to active arms.

Experimental: 125mg OEA with LipiSperse - Single dose of 2 capsules will be administered. 1 capsule will contain 125mg OEA and 13.9mg of LipiSperse and 1 capsule will be a placebo.

Experimental: 250mg OEA with LipiSperse - Single dose of 2 capsules will be administered. Each capsule will contain 125mg OEA and 13.9mg of LipiSperse.


Other interventions: Placebo
Single dose of 2 capsules. Capsules contain the same excipients as the active arms, except for the OEA with LipiSperse in capsules that appear identical to the OEA with LipiSperse capsules

Treatment: Other: 125mg OEA with LipiSperse
Single dose of 2 capsules. 1 capsule contains 125mg of OEA and 13.9mg of LipiSperse, the other capsule is a placebo.

Treatment: Other: 250mg OEA with LipiSperse
Single dose of 2 capsules. Each capsule contains 125mg of OEA and 13.9mg of LipiSperse.
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Changes in serum/plasma GLP-1 AUC
Timepoint [1] 0 0
Baseline and 8 hours
Secondary outcome [1] 0 0
Changes in serum/plasma GIP AUC
Timepoint [1] 0 0
Baseline and 8 hours
Secondary outcome [2] 0 0
Changes in serum/plasma DPP-4 AUC
Timepoint [2] 0 0
Baseline and 8 hours
Secondary outcome [3] 0 0
Changes in serum/plasma glucagon AUC
Timepoint [3] 0 0
Baseline and 8 hours
Secondary outcome [4] 0 0
Changes in serum/plasma glucose AUC
Timepoint [4] 0 0
Baseline and 8 hours
Secondary outcome [5] 0 0
Changes in serum/plasma insulin AUC
Timepoint [5] 0 0
Baseline and 8 hours
Secondary outcome [6] 0 0
Tmax of GLP-1
Timepoint [6] 0 0
Baseline to 8 hours
Secondary outcome [7] 0 0
Tmax of GIP
Timepoint [7] 0 0
Baseline to 8 hours
Secondary outcome [8] 0 0
Tmax of DPP-4
Timepoint [8] 0 0
Baseline to 8 hours
Secondary outcome [9] 0 0
Tmax of glucagon
Timepoint [9] 0 0
Baseline to 8 hours
Secondary outcome [10] 0 0
Tmax of glucose
Timepoint [10] 0 0
Baseline to 8 hours
Secondary outcome [11] 0 0
Tmax of insulin
Timepoint [11] 0 0
Baseline to 8 hours
Secondary outcome [12] 0 0
Cmax of GLP-1
Timepoint [12] 0 0
Baseline to 8 hours
Secondary outcome [13] 0 0
Cmax of GIP
Timepoint [13] 0 0
Baseline to 8 hours
Secondary outcome [14] 0 0
Cmax of DPP-4
Timepoint [14] 0 0
Baseline to 8 hours
Secondary outcome [15] 0 0
Cmax of glucagon
Timepoint [15] 0 0
Baseline to 8 hours
Secondary outcome [16] 0 0
Cmax of glucose
Timepoint [16] 0 0
Baseline to 8 hours
Secondary outcome [17] 0 0
Cmax of insulin
Timepoint [17] 0 0
Baseline to 8 hours
Secondary outcome [18] 0 0
Individual absorption data for each subject
Timepoint [18] 0 0
Baseline to 8 hours
Secondary outcome [19] 0 0
Tolerability including GIT tolerance
Timepoint [19] 0 0
Baseline to 8 hours
Secondary outcome [20] 0 0
Safety via AE monitoring
Timepoint [20] 0 0
Baseline to 8hours post dose
Secondary outcome [21] 0 0
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (AUC change in GLP-1)
Timepoint [21] 0 0
Baseline to 8 hours
Secondary outcome [22] 0 0
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (AUC change in GIP)
Timepoint [22] 0 0
Baseline to 8 hours
Secondary outcome [23] 0 0
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (AUC change in DPP-4)
Timepoint [23] 0 0
Baseline to 8 hours
Secondary outcome [24] 0 0
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (AUC change in glucagon)
Timepoint [24] 0 0
Baseline to 8 hours
Secondary outcome [25] 0 0
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (AUC change in glucose)
Timepoint [25] 0 0
Baseline to 8 hours
Secondary outcome [26] 0 0
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (AUC change in insulin)
Timepoint [26] 0 0
Baseline to 8 hours
Secondary outcome [27] 0 0
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (Tmax of GLP-1)
Timepoint [27] 0 0
Baseline to 8 hours
Secondary outcome [28] 0 0
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (Tmax of GIP)
Timepoint [28] 0 0
Baseline to 8 hours
Secondary outcome [29] 0 0
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (Tmax of DPP-4)
Timepoint [29] 0 0
Baseline to 8 hours
Secondary outcome [30] 0 0
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (Tmax of glucagon)
Timepoint [30] 0 0
Baseline to 8 hours
Secondary outcome [31] 0 0
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (Tmax of glucose)
Timepoint [31] 0 0
Baseline to 8 hours
Secondary outcome [32] 0 0
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (Tmax of insulin)
Timepoint [32] 0 0
Baseline to 8 hours
Secondary outcome [33] 0 0
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (CMax of GLP-1)
Timepoint [33] 0 0
Baseline to 8 hours
Secondary outcome [34] 0 0
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (CMax of GIP)
Timepoint [34] 0 0
Baseline to 8 hours
Secondary outcome [35] 0 0
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (CMax of DPP-4)
Timepoint [35] 0 0
Baseline to 8 hours
Secondary outcome [36] 0 0
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (CMax of glucagon)
Timepoint [36] 0 0
Baseline to 8 hours
Secondary outcome [37] 0 0
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (CMax of glucose)
Timepoint [37] 0 0
Baseline to 8 hours
Secondary outcome [38] 0 0
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (CMax of insulin)
Timepoint [38] 0 0
Baseline to 8 hours
Secondary outcome [39] 0 0
VAS for appetite
Timepoint [39] 0 0
Baseline to 4 hours
Secondary outcome [40] 0 0
Food consumption during the time in clinic (Lunch)
Timepoint [40] 0 0
Baseline to 8 hours.
Secondary outcome [41] 0 0
Food consumption during the time in clinic (Breakfast)
Timepoint [41] 0 0
Baseline to 8 hours.
Secondary outcome [42] 0 0
Food consumption during the time in clinic (snacks)
Timepoint [42] 0 0
Baseline to 8 hours.

Eligibility
Key inclusion criteria
* Adults aged 30 years and older
* Generally healthy
* BMI 25.0-34.9 kg/m2
* Able to provide informed consent
* Agree to not participate in another clinical trial while enrolled in this trial
* Agree not to change current diet and/or exercise frequency or intensity during entire study period
* Females using a prescribed form of birth control (e.g. oral contraceptive)
* Participant's ability to participate fully and comply with demands of the study including attendance at all scheduled blood collection time points
Minimum age
30 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Have a serious illness e.g. neurological disorders such as MS, kidney disease, liver disease or heart conditions
* History of any glucose or insulin regulation problem, including diabetes.
* Have an unstable illness e.g. thyroid gland dysfunction, uncontrolled mood disorders (e.g., depression, anxiety, bipolar).
* Diagnosed with any known metabolic or endocrine dysfunctions e.g., diabetes, NAFLD, hyperinsulinemia, hypoglycaemia.
* Use of any medication or supplements that may affect any metabolic pathway associated with satiety (e.g., GLP-1, GIP, glucagon), glucose or insulin.
* Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years
* Significant change in diet in the past 1-month (e.g., removal of a food group or calorie restriction)
* Active smokers, nicotine use or drug (prescription or illegal substances) abuse
* Chronic past and/or current alcohol use (>21 alcoholic drinks week)
* Pregnant or lactating women
* Allergic to any of the ingredients in active or placebo formula
* Participants who are or who have participated in any other clinical trial during the past 1 month (excludes RDC clinical trials which are to be assessed on a case-by-case basis).
* Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
* Regular use within the past 4 weeks of supplements containing OEA and/or LipiSperse

Study design
Purpose of the study
Other
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/03/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2026
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
RDC Clinical - Brisbane
Recruitment postcode(s) [1] 0 0
4006 - Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
RDC Clinical Pty Ltd
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Gencor Pacific Limited
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ramasamy Venkatesh
Address 0 0
Gencor Pacific
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
David Briskey
Address 0 0
Country 0 0
Phone 0 0
0061(0)421 784 077
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06840080